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The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients

NCT02764684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-10-11

No results posted yet for this study

Summary

Objective:

In this study the investigators aim at investigating:

1. probiotics ability to modulate the microbiome and microbial translocation,
2. if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and
3. if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract.

Design:

The study is a prospective clinical intervention trial of 40 HIV-infected patients.

Method:

The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.

Conditions

Interventions

DRUG

Probiotic

The probiotic strain Lactobacillus rhamnosus will be self-administrated twice a day, one capsule in the morning and one in the evening for eight weeks.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Susanne D Nielsen, MD, DMSc · Rigshospitalet, danmark

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-09-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764684 on ClinicalTrials.gov